The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Total Shoulder Prosthesis.
| Device ID | K950651 |
| 510k Number | K950651 |
| Device Name: | TOTAL SHOULDER PROSTHESIS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Contact | J. D Webb |
| Correspondent | J. D Webb ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-13 |
| Decision Date | 1995-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912143578 | K950651 | 000 |
| 00888912143493 | K950651 | 000 |
| 00888912143509 | K950651 | 000 |
| 00888912143516 | K950651 | 000 |
| 00888912143523 | K950651 | 000 |
| 00888912143530 | K950651 | 000 |
| 00888912143547 | K950651 | 000 |
| 00888912143554 | K950651 | 000 |
| 00888912143561 | K950651 | 000 |
| 00888912143486 | K950651 | 000 |
| 00888912143479 | K950651 | 000 |
| 00888912024334 | K950651 | 000 |
| 00888912024341 | K950651 | 000 |
| 00888912024365 | K950651 | 000 |
| 00888912143417 | K950651 | 000 |
| 00888912143424 | K950651 | 000 |
| 00888912143448 | K950651 | 000 |
| 00888912143455 | K950651 | 000 |
| 00888912143462 | K950651 | 000 |
| 00888912143585 | K950651 | 000 |
| 00888912143592 | K950651 | 000 |
| 00888912143608 | K950651 | 000 |
| 00888912143714 | K950651 | 000 |
| 00888912143738 | K950651 | 000 |
| 00888912143745 | K950651 | 000 |
| 00888912143752 | K950651 | 000 |
| 00888912143769 | K950651 | 000 |
| 00888912143776 | K950651 | 000 |
| 00888912143783 | K950651 | 000 |
| 00888912143813 | K950651 | 000 |
| 00888912143707 | K950651 | 000 |
| 00888912143691 | K950651 | 000 |
| 00888912143615 | K950651 | 000 |
| 00888912143622 | K950651 | 000 |
| 00888912143639 | K950651 | 000 |
| 00888912143646 | K950651 | 000 |
| 00888912143653 | K950651 | 000 |
| 00888912143660 | K950651 | 000 |
| 00888912143677 | K950651 | 000 |
| 00888912143684 | K950651 | 000 |
| 00888912143837 | K950651 | 000 |